四逆散双层渗透泵控释片片芯单因素考察

Single-factor investigation on the core components of Sinisan two-layer osmotic pump controlled-release tablets

目的研究四逆散双层渗透泵控释片的片芯各成分对体外释药的影响。方法分别将各因素不同处方在2、4、6、8、10、12h的累积释放度作为取样点,计算释药百分率,并以?2相似因子对各因素进行相似性判断,以考察不同因素对释药行为的影响。结果初步确定片芯处方为:药层NaCl30mg、聚氧化乙烯100mg,助推层聚氧化乙烯100mg、NaCl30mg。结论释药速率受药层PEO种类及用量、促渗剂的种类及用量影响较大,在一定范围内助推层中PEO、NaCl的用量对释放行为并无显著性影响。

Objective To study the influence of core components on the in vitro release of Sinisan two-layer osmotic pump controlled-release tablets. Method Influence of different factors on the in vitro release of the tablets was studied by sampling at 2,4,6,8,10,12 h and the cumulative release rate was calculated. Similar factor ?2 was used to evaluate the results. Results The selected composition of the core tablets was as follows:the drug layer was composed of NaCl 30 mg and polyoxyethylene 100 mg; the propelled layer was composed of polyoxyethylene 100 mg and NaCl 30 mg. Conclusion The drug release rate was considerably influenced by the type and amount of PEO,the type and amount of osmotic agent in the drug layer. In contrast,in a certain range the amount of PEO and NaCl in the propelled layer had no significant influence on drug release.